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United States · US · US:0074-3346_98a4f293-ee7c-44d0-9a1e-9dc7faf8aaf8
Lupron Depot
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAbbVie Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100743346031 KIT in 1 CARTON (0074-3346-03) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET
Annotations
Orange Book
N020517
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"e99f47d2-da10-3127-ecb3-e5d942ae6e81": {
"match": "brand_token",
"title": "LUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]",
"spl_version": "97",
"published_date": "2025-11-26"
}
},
"productid": "0074-3346_98a4f293-ee7c-44d0-9a1e-9dc7faf8aaf8",
"productndc": "0074-3346",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "020517",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "22.5MG",
"product_no": "001",
"approval_date": "Dec 22, 1995"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "30MG",
"product_no": "002",
"approval_date": "May 30, 1997"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "45MG",
"product_no": "003",
"approval_date": "Jun 17, 2011"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Lupron Depot",
"active_ingred_unit": null,
"application_number": "NDA020517",
"marketing_category": "NDA",
"nonproprietary_name": "leuprolide acetate",
"start_marketing_date": "19951222",
"active_numerator_strength": null
}Access this data programmatically
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